Desarrollo y validación del primer cuestionario español de calidad de vida en pacientes con cáncer de próstata, basado en la percepción del paciente
Development and validation of the first spanish questionnaire of quality of life in patients with prostate cancer, based on the patient’s perception
Francisco Gómez Veiga1,1
, M. José Olmo Cozar2, Stefan Günthner3, Miquel Puyol Pallas4, Ángel Silmi Moyano5, Eva Baró Ramos6, J. Francisco Rebollo7
Autor para correspondencia
fgveiga@telefonica.net
Correspondencia autor: Dr. Francisco Gómez Veiga Complej Hospitalario Universitario A Coruña Xubias de Arriba, 84 - 15006 A Coruña Tel.: 981 178 000
Correspondencia autor: Dr. Francisco Gómez Veiga Complej Hospitalario Universitario A Coruña Xubias de Arriba, 84 - 15006 A Coruña Tel.: 981 178 000
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"etiqueta" => "<span class="elsevierStyleSup">3</span>" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Hospital Sant Joan de Déu, Martorell (Barcelona)" "etiqueta" => "<span class="elsevierStyleSup">4</span>" "identificador" => "aff0020" ] 4 => array:3 [ "entidad" => "Hospital Clínico San Carlos, Madrid;" "etiqueta" => "<span class="elsevierStyleSup">5</span>" "identificador" => "aff0025" ] 5 => array:3 [ "entidad" => "3D-Health Research." "etiqueta" => "<span class="elsevierStyleSup">6</span>" "identificador" => "aff0030" ] 6 => array:3 [ "entidad" => "Abbott Laboratories S.A. España" "etiqueta" => "<span class="elsevierStyleSup">7</span>" "identificador" => "aff0035" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "1" "correspondencia" => "Correspondencia autor: Dr. Francisco Gómez Veiga Complej Hospitalario Universitario A Coruña Xubias de Arriba, 84 - 15006 A Coruña Tel.: 981 178 000" ] ] ] ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "Development and validation of the first spanish questionnaire of quality of life in patients with prostate cancer, based on the patient’s perception" ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2009-03-01" "fechaAceptado" => "2009-04-01" "PalabrasClave" => array:2 [ "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec88993" "palabras" => array:6 [ 0 => "Cuestionario" 1 => "Validez" 2 => "Factibilidad" 3 => "Fiabilidad" 4 => "Calidad de vida" 5 => "Cáncer de próstata" ] ] ] "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec88994" "palabras" => array:6 [ 0 => "Questionnaire" 1 => "Validity" 2 => "Feasibility" 3 => "Reliability" 4 => "Quality of life" 5 => "Prostate cancer" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "es" => array:2 [ "titulo" => "Resumen" "resumen" => "<span class="elsevierStyleSectionTitle">Introducción</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Asegurar calidad de vida relacionada con la salud(CVRS) durante la supervivencia del paciente con cáncer de próstata (CaP) es primordial. El desarrollo de cuestionarios específicos de CVRS facilita evaluar el impacto de la enfermedad, de su tratamiento y aspectos de percepción del paciente (preocupaciones, expectativas e intereses) que podrían pasar desapercibidos.</p> <span class="elsevierStyleSectionTitle">Objetivos</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Desarrollar y validar el primer cuestionario español de CVRS específico para pacientes con CaP.</p> <span class="elsevierStyleSectionTitle">Materiales y métodos</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">El cuestionario CAVIPRES tuvo 3 fases de desarrollo: 1-generación de ítems (investigación documental, sesión de expertos y 2 grupos de discusión con pacientes), 2-reducción de ítems (encuesta auto administrada con el precuestionario y análisis clinimétrico y psicométrico), 3: validación del cuestionario (estudio observacional con 2 entrevistas al paciente que completaba los tests CAVIPRES, SF-36 y UCLA-PCI y análisis de propiedades psicométricas en términos de validez, fiabilidad y sensibilidad al cambio). Resultados: La fase 1 generó un precuestionario de 75 potenciales ítems. En la fase 2, 412 pacientes respondieron a la versión preliminar y se excluyeron 35 ítems. En la fase 3, 436 pacientes respondieron a la versión prevalidada. Se obtuvo un cuestionario de 30 ítems para investigación clínica (CAVIPRES-30). El CAVIPRES-30 mostró viabilidad (ítems perdidos <4%), factibilidad (efecto techo: 0% y efecto suelo: 0% en la puntuación global), alta fiabilidad en cuanto a consistencia interna (alfa=0,77) y a fiabilidad re-test (CCI=0,92). Hubo una buena correlación entre CAVIPRES y los tests SGF-36 y UCLA-PCI para dimensiones semejantes.</p> <span class="elsevierStyleSectionTitle">Conclusión</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">El cuestionario CAVIPRES-30 es un instrumento factible, fiable y sensible al cambio, útil en la investigación clínica del cáncer de próstata.</p>" ] "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span class="elsevierStyleSectionTitle">Background</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">To ensure health related quality of life (HRQOL) during the survival of patients with prostate cancer (PCa) is a priority. The development of specific HRQOL questionnaires aids to assess the disease impact, its treatment and the patient’s perception (concerns, expectations and interests) that might go unnoticed.</p> <span class="elsevierStyleSectionTitle">Objectives</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">To develop and validate the first Spanish HRQL questionnaire specific for patients with PCa.</p> <span class="elsevierStyleSectionTitle">Materials and methods</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">The questionnaire CAVIPRES had 3 phases of development:1.-generation of items (literature research, expert meeting and 2 focus groups with patients), 2.- reduction of items (self-administered survey with a preliminary version and clinimetric and psychometric analyses), 3: validation of the questionnaire (observational study with 2 visits where patients completed the CAVIPRES, SF-36 and UCLA-PCI tests and analysis of psychometric properties in terms of validity, reliability and sensitivity to change).</p> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">A preliminary list of 75 potential items was obtained in phase 1.412 patients were recruited and answered this preliminary version in phase 2. 35 items were deleted. 436 patients responded to the definitive-30-ítems obtained version (CAVIPRES- 30) in Phase 3. CAVIPRES-30 showed feasibility (items lost <4%, ceiling effect: 0% floor effect: 0% in the overall score), high reliability in terms of internal consistency (alpha = 0.77) and re-test reliability (ICC = 0.92). There was a good correlation between tests CAVIPRES and SGF-36 and UCLA-PCI for similar domains</p> <span class="elsevierStyleSectionTitle">Conclusion</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">The questionnaire CAVIPRES-30 is a feasible, reliable and sensitive to change, useful in clinical research for prostate cancer.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "Referencias" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:30 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1." "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Measuring health-related quality of life in men with prostate cancer." 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| 2021 Octubre | 0 | 3 | 3 |
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| 2020 Septiembre | 0 | 7 | 7 |
| 2020 Agosto | 0 | 7 | 7 |
| 2020 Julio | 0 | 2 | 2 |
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| 2020 Mayo | 0 | 7 | 7 |
| 2020 Abril | 0 | 7 | 7 |
| 2020 Marzo | 0 | 8 | 8 |
| 2020 Febrero | 0 | 8 | 8 |
| 2020 Enero | 0 | 12 | 12 |
| 2019 Diciembre | 0 | 11 | 11 |
| 2019 Noviembre | 0 | 13 | 13 |
| 2019 Octubre | 0 | 10 | 10 |
| 2019 Septiembre | 0 | 12 | 12 |
| 2019 Agosto | 0 | 6 | 6 |
| 2019 Julio | 0 | 14 | 14 |
| 2019 Junio | 0 | 25 | 25 |
| 2019 Mayo | 0 | 54 | 54 |
| 2019 Abril | 1 | 41 | 42 |
| 2019 Marzo | 0 | 4 | 4 |
| 2019 Febrero | 0 | 20 | 20 |
| 2019 Enero | 0 | 7 | 7 |
| 2018 Diciembre | 0 | 9 | 9 |
| 2018 Noviembre | 0 | 18 | 18 |
| 2018 Octubre | 0 | 19 | 19 |
| 2018 Septiembre | 0 | 2 | 2 |
| 2018 Agosto | 0 | 9 | 9 |
| 2018 Julio | 0 | 2 | 2 |
| 2018 Junio | 0 | 2 | 2 |
| 2018 Marzo | 0 | 1 | 1 |
| 2018 Febrero | 4 | 4 | 8 |
| 2018 Enero | 3 | 4 | 7 |
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| 2017 Noviembre | 3 | 7 | 10 |
| 2017 Octubre | 16 | 4 | 20 |
| 2017 Septiembre | 7 | 10 | 17 |
| 2017 Agosto | 3 | 1 | 4 |
| 2017 Julio | 9 | 3 | 12 |
| 2017 Junio | 7 | 3 | 10 |
| 2017 Mayo | 7 | 17 | 24 |
| 2017 Abril | 14 | 5 | 19 |
| 2017 Marzo | 19 | 9 | 28 |
| 2017 Febrero | 8 | 2 | 10 |
| 2017 Enero | 3 | 6 | 9 |
| 2016 Diciembre | 25 | 5 | 30 |
| 2016 Noviembre | 23 | 6 | 29 |
| 2016 Octubre | 28 | 9 | 37 |
| 2016 Septiembre | 13 | 7 | 20 |
| 2016 Agosto | 12 | 5 | 17 |
| 2016 Julio | 20 | 13 | 33 |
| 2016 Junio | 15 | 20 | 35 |
| 2016 Mayo | 18 | 38 | 56 |
| 2016 Abril | 16 | 14 | 30 |
| 2016 Marzo | 16 | 25 | 41 |
| 2016 Febrero | 13 | 18 | 31 |
| 2016 Enero | 20 | 27 | 47 |
| 2015 Diciembre | 18 | 23 | 41 |
| 2015 Noviembre | 6 | 15 | 21 |
| 2015 Octubre | 21 | 20 | 41 |
| 2015 Septiembre | 15 | 7 | 22 |
| 2015 Agosto | 7 | 5 | 12 |
| 2015 Julio | 7 | 8 | 15 |
| 2015 Junio | 9 | 0 | 9 |
| 2015 Mayo | 11 | 25 | 36 |
| 2015 Abril | 10 | 14 | 24 |
| 2015 Marzo | 15 | 11 | 26 |
| 2015 Febrero | 8 | 5 | 13 |
| 2015 Enero | 10 | 8 | 18 |
| 2014 Diciembre | 11 | 15 | 26 |
| 2014 Noviembre | 5 | 3 | 8 |
| 2014 Octubre | 15 | 4 | 19 |
| 2014 Septiembre | 10 | 2 | 12 |
| 2014 Agosto | 6 | 1 | 7 |
| 2014 Julio | 16 | 2 | 18 |
| 2014 Junio | 6 | 5 | 11 |
| 2014 Mayo | 1 | 1 | 2 |
| 2014 Abril | 2 | 5 | 7 |
| 2014 Marzo | 3 | 1 | 4 |
| 2014 Febrero | 6 | 4 | 10 |
| 2014 Enero | 4 | 3 | 7 |
| 2013 Diciembre | 5 | 4 | 9 |
| 2013 Noviembre | 13 | 20 | 33 |
| 2013 Octubre | 4 | 18 | 22 |
| 2013 Septiembre | 6 | 13 | 19 |
| 2013 Agosto | 4 | 22 | 26 |
| 2013 Julio | 1 | 3 | 4 |
| 2009 Mayo | 583 | 0 | 583 |
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